BEUDAMED
    FDA Registration Active 🇳🇱 Netherlands

    EVA Nexus Infusion and Aux. Aspiration Tubing

    Reg #: 9611516 · FEI: 3002806863 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    23
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
    Registration Number
    9611516
    FEI Number
    3002806863
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    SCHEIJDELVEWEG 2
    City
    ZUIDLAND Zuid-Holland
    Country
    NL

    Regulatory Submissions

    510(k) Number
    K213467

    Owner / Operator

    Firm Name
    D.O.R.C. Dutch Ophthalmic Research Center (International) B.
    Operator Number
    8030460
    Address
    SCHEIJDELVEWEG 2, --
    City
    ZUIDLAND
    State
    Zuid-Holland
    Postal Code
    3214 VN
    Country
    NL
    Correspondent
    Michel - van der Schans

    US Agent

    Business Name
    Dutch Ophthalmic USA
    Contact Name
    Deborah Thibodeaux
    Address
    10 Continental Drive, Bldg 1
    City
    Exeter
    State
    NH
    ZIP
    03833
    Country
    US
    Email
    [email protected]
    Phone
    603 7786929 ext. 170

    Products

    Device Name Product Code
    Syringe, Piston FMF
    Laser, Ophthalmic HQF
    Unit, Phacofragmentation HQC
    Instrument, Vitreous Aspiration And Cutting, Ac-Powered HQE

    Proprietary Names

    EVA Nexus Infusion and Aux. Aspiration Tubing EVA Nexus Infusion Tubing Two Dimensional Cutter – 20k CPM EVA NEXUS, Phaco vitrectomy system including laser with DORC connector EVA NEXUS Custom Phaco Pack 30 (Angled) EVA NEXUS Custom cartridge with 0,5 l collection bag EVA NEXUS cartridge with 0,5 L collection bag EVA NEXUS Custom Phaco Pack 45 (Straight) EVA Nexus Aux. Aspiration Tubing EVA NEXUS Infusion Giving Set EVA NEXUS Combined TDC Pack EVA NEXUS Posterior TDC Pack EVA Nexus Irrigation Tubing EVA NEXUS Digital Overlay System EVA NEXUS Custom Phaco Pack 45 (Angled) EVA NEXUS, Phaco emulsification system 1cc syringe holder for micro-injection EVA NEXUS, Phaco vitrectomy system Directional Laser Probe with Alcon / Lumenis connector Directional Laser Probe with DORC connector EVA NEXUS, Phaco vitrectomy system including laser with SMA connector EVA NEXUS Custom Phaco Pack 30 (Straight) EVA NEXUS Irrigation and Aux. Aspiration Tubing

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device